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Spectroscopy in Parkinson Disease (SPIN-PD)

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ClinicalTrials.gov Identifier: NCT01005030
Recruitment Status : Unknown
Verified November 2009 by Molecular Biometrics, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : October 30, 2009
Last Update Posted : November 10, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The primary objective of the study is to determine the utility of blood plasma infrared spectroscopy (biospectroscopy) in distinguishing subjects with idiopathic Parkinson's disease from healthy controls.

Condition or disease Intervention/treatment
Parkinson Disease Other: Blood draw

Detailed Description:
Oxidative stress has been implicated as a factor in the pathogenesis of Parkinson's disease (PD). The overall goal of this proposal is to use a novel metabolomics platform, based on near infrared biospectroscopy, to detect oxidatively modified blood plasma constituents. These spectral findings can be used to model the degree of oxidative stress with a modeled "stress index" that may distinguish PD cases from healthy elderly controls.

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Blood Biospectroscopy as a Novel Diagnostic Test for Idiopathic Parkinson Disease
Study Start Date : October 2009
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
PostCEPT Subjects
Subjects with current Parkinson Disease Diagnosis currently enrolled in PostCEPT study
Other: Blood draw
Blood draw, two tubes, used for isolation of cell-free blood plasma
Control Subjects
Non-blood relatives of PostCEPT Subjects matched for age and other demographics
Other: Blood draw
Blood draw, two tubes, used for isolation of cell-free blood plasma


Outcome Measures

Primary Outcome Measures :
  1. The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity. [ Time Frame: Baseline and annually for two years ]

Secondary Outcome Measures :
  1. Determine impact of disease stage, age, gender, medications, cognitive scores, other laboratory measures (e.g. alpha-synuclein) and other clinical/demographic variables on plasma biospectra. [ Time Frame: Baseline and annually for two years ]
  2. Correlate plasma biospectra with dopamine transporter neuroimaging data. [ Time Frame: Baseline and annually for two years ]

Biospecimen Retention:   Samples Without DNA
Blood plasma, cell free

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   46 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's subjects: from pool of subjects currently enrolled in PostCEPT study Control subjects: general population
Criteria

Inclusion Criteria:

PD Subjects:

  1. PostCEPT subjects with a diagnosis of PD based on UK Brain Bank criteria.
  2. Willing and able to provide informed consent.

Healthy Controls:

  1. No current diagnosis or known history of a neurological disease/disorder.
  2. Non-blood relative of a patient or subject at the site who has diagnosis of PD (may include healthy controls from the PROBE study).
  3. No first degree relatives with diagnosis of PD
  4. MoCA score > 26.
  5. Age > 45.
  6. Willing and able to provide informed consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005030


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14620
Sponsors and Collaborators
Molecular Biometrics, Inc.
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Bernard Ravina, MD University of Rochester
Principal Investigator: Anthony E Lang, MD University of Toronto
More Information

Additional Information:
Publications:
Responsible Party: Bruce J. Goldstein / Vice President, Operations, Molecular Biometrics, Inc.
ClinicalTrials.gov Identifier: NCT01005030     History of Changes
Other Study ID Numbers: MB_PD001
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Molecular Biometrics, Inc.:
Parkinson Disease
blood
plasma
metabolomics
spectroscopy
oxidative stress.

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases